The Plenaxis® Experience Study

This study has suspended participant recruitment.
Sponsor:
Information provided by:
PRAECIS Pharmaceuticals Inc.
ClinicalTrials.gov Identifier:
NCT00103623
First received: February 11, 2005
Last updated: September 18, 2006
Last verified: September 2006
  Purpose

Praecis is currently conducting a 2000 patient Experience Study; this is a Phase IV commitment postmarketing safety study in the Food and Drug Administration (FDA) indicated population of patients receiving Plenaxis®. The purpose of the study is to estimate the incidence of immediate-onset systemic allergic reactions in the indicated population receiving Plenaxis® and to determine whether the hazard rate changes over time.


Condition Intervention Phase
Prostate Cancer
Drug: Plenaxis
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Incidence of Immediate Onset Systemic Allergic Reactions in Patients Treated With Plenaxis®

Resource links provided by NLM:


Further study details as provided by PRAECIS Pharmaceuticals Inc.:

Primary Outcome Measures:
  • Estimate the incidence of immediate-onset systemic allergic reactions in the indicated population receiving Plenaxis

Estimated Enrollment: 2000
Study Start Date: June 2004
Estimated Study Completion Date: December 2008
Detailed Description:

This is a postmarketing patient safety study in the FDA indicated population of patients receiving Plenaxis®. On a quarterly basis, patients enrolled in the Plenaxis® Experience Study will have their charts audited to record the number of immediate-onset systemic allergic reactions that may occur while receiving Plenaxis®. The study will close when 2,000 patients have been enrolled. If immediate onset allergic reactions occur, patients may be eligible to enroll in a second protocol (skin testing in patients who experience an immediate onset allergic reaction). Collection of all immediate-onset systemic allergic reactions will continue for each patient enrolled in the study until the patient discontinues Plenaxis® for any reason, the patient withdraws consent to continue in the study or the patient is lost to follow-up.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

A subject is eligible to participate in the study if he meets the following criteria:

  • Male ≥ 18 years old with advanced symptomatic prostate cancer for whom LHRH agonist therapy is not appropriate and who refuses surgical castration
  • Has at least one of the following:

    1. Risk of neurological compromise due to metastases,
    2. Ureteral or bladder outlet obstruction due to local encroachment or metastatic disease or
    3. Severe bone pain from skeletal metastases persisting on narcotic analgesia
  • Patients or their legal representatives must be able to read, understand and sign an informed consent form to participate in the trial.

Exclusion Criteria:

  • Female Patients,
  • Pediatric patients,
  • Patients with known hypersensitivity to any of the components in the abarelix injectable suspension
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00103623

  Hide Study Locations
Locations
United States, Alabama
Millenium Therapeutics & Research - Urology Practice
Birmingham, Alabama, United States, 35205
United States, Arizona
Valley Urologic Associates
Goodyear, Arizona, United States, 85338
Foundation for Cancer Research and Education
Phoenix, Arizona, United States, 85013
Arizona Urologic Specialists
Tucson, Arizona, United States, 85712
United States, California
Alfred Sidhom, MD, FACS, PC
Anaheim, California, United States, 92801
Dr. Chris Threatt
Atherton, California, United States, 94027
Hematology-Oncology Group of Fresno
Fresno, California, United States, 93720
South Orange County Medical Research Center
Laguna Woods, California, United States, 92653
Atlantic Urological Medical Group
Long Beach, California, United States, 90806
Paul Neustein, MD. INC
Poway, California, United States, 92064
San Diego Urology
San Diego, California, United States, 91942
Sherman Oaks Urological Medical Group, Inc.
Sherman Oaks, California, United States, 91403
United States, Colorado
Urology Associates PC
Denver, Colorado, United States, 80210
United States, Florida
Urologic Associates
Fort Meyers, Florida, United States, 33919
Southwest Florida Urologic Associates
Fort Myers, Florida, United States, 33907
University of Florida Shands Jacksonville
Jacksonville, Florida, United States, 32209
UroSearch
Ocala, Florida, United States, 34470
Urology Associates of Ocala, P.A.
Ocala, Florida, United States, 34474
South Florida Urology Center, Inc.
Pembroke Pines, Florida, United States, 33028
South Florida Urology Center Inc
Pembroke Pines, Florida, United States, 33028
Uro-Medix, Inc
Sunrise, Florida, United States, 33351
Osvaldo F. Padron MD, FACS
Tampa, Florida, United States, 33614
Urological Surgical Services
Tavares, Florida, United States, 32778
Osler Medical
West Melbourne, Florida, United States, 32901
United States, Georgia
Urology Associates, P.C.
Marietta, Georgia, United States, 30060
United States, Illinois
Praire Medical Associates, LTD
Chicago, Illinois, United States, 60616
Midwest Prostate Urology Health Center
Chicago, Illinois, United States, 60640
United States, Indiana
Urology of Indiana
Indianapolis, Indiana, United States, 46254
Unity HealthCare DBA Lafayette Clinic of Urology
Lafayette, Indiana, United States, 47905
United States, Iowa
Heartland Oncology and Hematology
Council Bluffs, Iowa, United States, 51503
United States, Kansas
Private Practice
Emporia, Kansas, United States, 66801
KUMC Department of Urology
Kansas City, Kansas, United States, 66160
United States, Massachusetts
Tri-County Urology
Milford, Massachusetts, United States, 01757
Bay State Clinical Trials Inc
Watertown, Massachusetts, United States, 02472
United States, Michigan
Tewodros Fresseha MD PC
Southfield, Michigan, United States, 48075
Lakeside Urology
St. Joseph, Michigan, United States, 49085
United States, Missouri
Midwest Urology
Independence, Missouri, United States, 64055
Kansas City Urology Care
Kansas City, Missouri, United States, 64131
United States, Nebraska
Quality Clinical Research, LLC
Omaha, Nebraska, United States, 68114
United States, Nevada
Sheldon j. Freedman, MD Ltd
Las Vegas, Nevada, United States, 89109
United States, New Jersey
Essex-Hudson Urology
Bloomfield, New Jersey, United States, 07003
Hunterdon Urological Associates, PA
Flemington, New Jersey, United States, 08822
Northwest Urology Associates
Morristown, New Jersey, United States, 07960
Roseland Surgical Suite
Roseland, New Jersey, United States, 07068
Urology Healthcare Associates/Rancocas Medical Center
Willingboro, New Jersey, United States, 08046
United States, New York
Staten Island Urological Research, PC
Staten Island, New York, United States, 10304
United States, North Carolina
University of North Carolina, Chapel Hill
Chapel Hill, North Carolina, United States, 27599
American Health Research
Charlotte, North Carolina, United States, 28207
Northeast Urology Research
Concord, North Carolina, United States, 28025
Washington Urological Associates
Washington, North Carolina, United States, 27889
United States, Ohio
Columbus Urology Research
Columbus, Ohio, United States, 43214
United States, Oklahoma
Parkhurst Research Organization
Bethany, Oklahoma, United States, 73008
United States, Pennsylvania
Bryn Mawr Urology
Devon, Pennsylvania, United States, 19333
Dr. Peter Sinaiko
Langhorne, Pennsylvania, United States, 19047
Urology and Urological Oncology
Philadelphia, Pennsylvania, United States, 19141
Triangle Urological Group
Pittsburgh, Pennsylvania, United States, 15212
United States, South Carolina
Carolina Urologic Research Center
Myrtle Beach, South Carolina, United States, 29572
United States, Texas
Dr. Greg Echt
Irving, Texas, United States, 75062
United States, Washington
North West Prostate Institute
Seattle, Washington, United States, 98133
Roger D. Fincher, MD
Spokane, Washington, United States, 99202
Sponsors and Collaborators
PRAECIS Pharmaceuticals Inc.
Investigators
Study Director: Gerald Riedel, PhD PRAECIS Pharmaceuticals Inc.
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00103623     History of Changes
Other Study ID Numbers: 149-IV-01
Study First Received: February 11, 2005
Last Updated: September 18, 2006
Health Authority: United States: Food and Drug Administration

Keywords provided by PRAECIS Pharmaceuticals Inc.:
Advanced
Symptomatic
Prostate
Cancer
Advanced Symptomatic Prostate Cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Abarelix
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 29, 2014